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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED IP-EC-VIDEO-EXT
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NATUS MEDICAL INCORPORATED IP-EC-VIDEO-EXT Back to Search Results
Model Number IP-EC-VIDEO-EXT
Device Problems Break (1069); Crack (1135); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/31/2023
Event Type  malfunction  
Event Description
Ip ptz ergojust video extension: cart has cracked video extension.Pictures provided of the failure were reviewed and it was noted the bracket does not look to be installed on the customer's equipment.No injuries.
 
Manufacturer Narrative
Initial report ref to natus complaint# (b)(4).Capa003910 and capa003957 previously created to address this issue.Eco##27338 was implemented :hooks added to hold the upper mast to the cross plate.Tabs and slots added to hold the mounting area of the mast to the cross plate.Per qms-004442 complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Per doc-010378 xltek eeg psg risk analysis spreadsheet, hazard id - 6.11, severity 11- critical, the risk is considered moderate.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.A dhr review is not applicable because, prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is very unlikely.Install date: (b)(6) 2020.Further review to be carried out.
 
Manufacturer Narrative
Follow up report 001 ref to natus complaint#(b)(4).A replacement part was sent to address the issue.Technical service have requested the customer to return the affected device for evaluation.To date, the device has not been returned.A reminder to return the product was sent to the customer (b)(6) 2023, (b)(6) 2023, and the (b)(6) 2023.No response to date.·.
 
Event Description
Ip ptz ergojust video extension - cart has cracked video extension.Pictures provided of the failure were reviewed and it was noted the bracket does not look to be installed on the customer's equipment.No injuries.
 
Event Description
Ip ptz ergojust video extension - cart has cracked video extension.Pictures provided of the failure were reviewed and it was noted the bracket does not look to be installed on the customer's equipment.No injuries.
 
Manufacturer Narrative
Follow up report 002 ref to natus complaint#(b)(4).Device was returned on 13-dec-2023.Investigation results: one video extension was returned with both inner welds broken.((b)(6)).The tabs on both sides were bent, as would happen if the welds broke and the tabs were supporting the weight of the mast.The customer noticed that the mast was wobbly and correctly took it out of service before the mast fell.Root cause/probable root cause: welds failed due to unknown cause, could be misuse.Recommended actions: monitor for similar incidents, secondary features worked as designed to prevent the mast from falling.If more issues are seen with the quality of the welds discuss with the supplier of the mast.Investigator completion date: 07-feb-2024.
 
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Brand Name
IP-EC-VIDEO-EXT
Type of Device
IP-EC-VIDEO-EXT
Manufacturer (Section D)
NATUS MEDICAL INCORPORATED
dba excel-tech ltd. (xltek)
2568 bristol circle
oakville, ontario l6h 5s1,
CA 
Manufacturer (Section G)
NATUS MANUFACTURING LIMITED
ida business park
gort
galway h91pd92,
EI  
Manufacturer Contact
grainne walsh
dba excel-tech ltd. (xltek)
2568 bristol circle
oakville, ontario l6h 5s1, 
CA  
MDR Report Key17554904
MDR Text Key321931914
Report Number9612330-2023-00024
Device Sequence Number1
Product Code OMB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIP-EC-VIDEO-EXT
Device Catalogue NumberIP-EC-VIDEO-EXT
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received07/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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